Serum Institute partners with RDIF to make 300 mn doses of Sputnik V

Sputnik V’s production in India has received a shot in the arm as the developers of the Russian Covid-19 vaccine and Serum Institute of India (SII) announced a partnership agreement on Tuesday to manufacture more than 300 million doses, with production set to start in September. With this deal, the total manufacturing capacity for Sputnik V in India crosses 1.1 billion doses annually.

As Kirill Dmitriev, chief executive officer (CEO), Russian Direct Investment Fund (RDIF), the Russian sovereign wealth fund, pointed out, SII will be in a position to produce the mix-and-match dose combination of the AstraZeneca-Oxford vaccine and Sputnik V.

Speaking to reporters from Moscow, Dmitriev said the trial of mix-and-match vaccines at Azerbaijan is expected to be over soon; the initial results could be out as early as end-July.

Human trials of a Covid vaccine combining the AstraZeneca-Oxford shot with Sputnik V had been approved in Azerbaijan, the United Arab Emirates, and Belarus. The Azerbaijan trials had begun around March this year.

Dmitriev told reporters that Sputnik V was the first in the world to suggest that the two shots should be different to give a stronger and longer immune response. Sputnik V is a heterogeneous vaccine — it uses two different components in two shots. The first shot uses the human adenovirus vector Ad26, while the second one uses Ad5.

SII is already making Covishield, the AstraZeneca vaccine. Once approved, SII will be in a position to manufacture the combination-dose vaccine of the Sputnik V and AstraZeneca too, and it can also make the booster shots.

Adar Poonawalla, CEO of SII, said “We hope to make millions of doses in the coming months, with trial batches starting in September.”

The Pune-based vaccine maker, the world’s largest manufacturer in terms of doses, has already produced over 500 million doses of the Covid vaccine, said RDIF. In addition to developing its own vaccine, it is currently manufacturing Covishield, Covovax (by Novavax), and conducting trials of the Codagenix in the UK.

As part of the technical transfer process, SII has already received cell and vector samples from the Gamaleya National Center of Epidemiology and Microbiology. With their import approved by the Drugs Controller General of India, the cultivation process has begun.

India is the leading production hub for the production of the Sputnik vaccine. The RDIF had earlier reached agreements with a number of pharmaceutical companies in India (Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech, and Morepen) for the production of the Russian vaccine — more than 850 million doses per year. Around 250 million doses are planned for India at the moment.

Dmitriev said some of these partners have started manufacturing the Sputnik V, and the quality has been verified by the Gamaleya Center. The production from these partners is expected to be available by September, he added.

The Indian production is critical for the commercial launch of Sputnik V, which is delayed on account of shortage of the second dose component of the vaccine. Dr. Reddy’s Laboratories (DRL), which is the distribution partner of RDIF for Sputnik V, launched a pilot on May 14. While the nationwide soft launch has reached 50 cities, the vaccine is yet to be commercially launched.

DRL had said earlier that there was a “slight postponement in timeline of the commercial launch due to dependency on imported consignments”. DRL is the sole distributor of the first 250 million doses of the Sputnik V vaccine in India. The initial 50 million doses are expected to be imported from Russia to ensure faster roll-out in India as Indian manufacturing sites gear up to supply the vaccine.

The first consignment of the imported doses of the Sputnik V vaccine, which landed in India on May 1, received regulatory clearance from the Central Drugs Laboratory in Kasauli on May 13.

The imported doses of the vaccine are currently priced at a maximum retail price of Rs 948 plus 5 per cent goods and services tax per dose, with the possibility of a lower price point when local supply begins, said DRL.

To date, the Russian Sputnik V vaccine has been registered in 67 countries globally, with a total population of over 3.5 billion people. The vaccine has shown an efficacy of 97.6 per cent, based on the analysis of the data on the coronavirus infection rate among those in Russia vaccinated with both components of the Sputnik V between December 5, 2020, and March 31, 2021.